Music vs Midazolam During Preop Nerve Block Placement



Status:Completed
Conditions:Anxiety, Anxiety
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:April 12, 2017
End Date:May 11, 2018

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Music vs Midazolam During Preoperative Nerve Block Placement: A Prospective, Randomized Controlled Study

The purpose of this study is to determine if there are differences in anxiety scores, heart
rate, blood pressure, and oxygen status when using sedation medication versus music while
undergoing a peripheral nerve block before your surgery.

The general flow of the study will be conducted as follows:

1. Research coordinator will call or approach patients who are scheduled for a surgical
procedure that is planning for a peripheral nerve block either for the primary
anesthetic or for postoperative pain control to be placed in the preoperative bay in the
ambulatory surgical center.

2. Research coordinator will discuss the purpose of our study and explain the study in
detail for the patient. If a patient agrees to participate, then we will have the
patient sign the informed consent for the study. If patient is on the phone and decides
to participate, the patient will sign the informed consent upon arriving to Penn
Medicine University City (PMUC).

3. Once the patient signs the informed consent for the peripheral nerve block by anesthesia
team. The patient randomized will be revealed to either music or IV midazolam. The
pre-procedure anxiety score will then be obtained using the STAI-6 validated tool.

4. The golden moment will be conducted between the patient, provider, and nursing staff.
Once this golden moment is completed, the anxiolytic intervention will start (music or
IV midazolam)*

5. The preoperative nerve block will be conducted by the regional anesthesia block team.

6. Once the nerve block is complete, we will obtain the post-procedure anxiety score using
the STAI-6 validated tool.

7. Once the post-procedure anxiety score has been obtained, we will also obtain the patient
satisfaction score, the provider satisfaction score, and the evaluation of any
difficulties in communication between the provider and patient. After these questions
have been obtained, the study is complete.

Inclusion Criteria:

- Patients who are >18 years of age, who will give informed consent in receiving a
peripheral nerve block in the preoperative bay for their primary anesthetic and/or for
their postoperative pain control.

Exclusion Criteria:

- significant psychiatric disorder such as generalized anxiety disorder, panic disorder,
depression, psychosis, bipolar disorder; individuals who were incompetent to give
informed consent; pregnant and/or breast feeding patients; any underlying
coagulopathy, infection or other factors which would be a contraindication to
receiving a peripheral nerve block; hypersensitivity to midazolam; and history of
renal impairment. Patients who were extremely anxious (scores 50 and greater on the
State Trait Anxiety Inventory-6 (STAI-6) tool) were also excluded from the study.
We found this trial at
1
site
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Veena Graff, MD, MS
Phone: 610-248-9286
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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mi
from
Philadelphia, PA
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